NCT00535509

Brief Summary

Phase II trial of Neoadjuvant \[FEC100\]/Cisplatin-Docetaxel ± Trastuzumab in women with over expressed or amplified Her2/Neu with Locally advanced Breast Cancer

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 17, 2015

Status Verified

December 1, 2015

Enrollment Period

6 years

First QC Date

September 24, 2007

Last Update Submit

December 16, 2015

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    overall

Interventions

Cisplatin-Docetaxel ± TrastuzumabRADIATION

Chemo \& RT

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with locally advanced breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Taher Twegieri, MD

    KFSH&RC

    PRINCIPAL INVESTIGATOR

  • Dahish Ajarim, MD

    KFSH&RC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

June 1, 2007

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 17, 2015

Record last verified: 2015-12